| nk | NO-GO | Continue | GO |
|---|---|---|---|
| Slope, %: -10% | |||
| 20 | 0.44 | 0.56 | 0.00 |
| 30 | 0.60 | 0.40 | 0.00 |
| 40 | 0.72 | 0.28 | 0.00 |
| 60 | 1.00 | ||
| 80 | 1.00 | ||
| Slope, %: 0% | |||
| 20 | 0.22 | 0.76 | 0.02 |
| 30 | 0.32 | 0.65 | 0.03 |
| 40 | 0.41 | 0.56 | 0.03 |
| 60 | 0.55 | 0.43 | 0.02 |
| 80 | 0.69 | 0.28 | 0.03 |
| Slope, %: 10% | |||
| 20 | 0.08 | 0.83 | 0.09 |
| 30 | 0.12 | 0.76 | 0.12 |
| 40 | 0.15 | 0.69 | 0.16 |
| 60 | 0.35 | 0.24 | 0.41 |
| 80 | 0.41 | 0.07 | 0.52 |
| Slope, %: 20% | |||
| 20 | 0.02 | 0.73 | 0.25 |
| 30 | 0.03 | 0.61 | 0.36 |
| 40 | 0.03 | 0.51 | 0.46 |
| 60 | 0.04 | 0.05 | 0.91 |
| 80 | 0.02 | 0.00 | 0.98 |
| Slope, %: 30% | |||
| 20 | 0.01 | 0.49 | 0.50 |
| 30 | 0.00 | 0.36 | 0.63 |
| 40 | 0.00 | 0.22 | 0.78 |
| 60 | 0.00 | 1.00 | |
| 80 | 1.00 | ||
| Slope, %: 40% | |||
| 20 | 0.00 | 0.29 | 0.71 |
| 30 | 0.00 | 0.12 | 0.88 |
| 40 | 0.04 | 0.96 | |
| 60 | 1.00 | ||
| 80 | 1.00 | ||
When theta_mav = 0, theta_TV = 20, tau_mav = tau_TV = 0.025.
| true.slope | nk | Criterion | NO-GO | Continue | GO |
|---|---|---|---|---|---|
| Relative TTP slope: -10% | |||||
| -10% | 20 | other | 18 (1.8) | 547 (54.7) | |
| -10% | 20 | Unfavorable outcome only | 17 (1.7) | ||
| -10% | 20 | TPP only | 418 (41.8) | ||
| -10% | 30 | other | 122 (12.2) | 314 (31.4) | |
| -10% | 30 | Unfavorable outcome only | 83 (8.3) | ||
| -10% | 30 | TPP only | 481 (48.1) | ||
| -10% | 40 | other | 386 (38.6) | 149 (14.9) | |
| -10% | 40 | Unfavorable outcome only | 131 (13.1) | ||
| -10% | 40 | TPP only | 334 (33.4) | ||
| Relative TTP slope: 10% | |||||
| 10% | 20 | other | 3 (0.3) | 848 (84.8) | 35 (3.5) |
| 10% | 20 | Unfavorable outcome only | 32 (3.2) | ||
| 10% | 20 | TPP only | 82 (8.2) | ||
| 10% | 30 | other | 20 (2) | 681 (68.1) | 22 (2.2) |
| 10% | 30 | Unfavorable outcome only | 185 (18.5) | ||
| 10% | 30 | TPP only | 92 (9.2) | ||
| 10% | 40 | other | 86 (8.6) | 428 (42.8) | 5 (0.5) |
| 10% | 40 | Unfavorable outcome only | 431 (43.1) | ||
| 10% | 40 | TPP only | 50 (5) | ||
| Relative TTP slope: 35% | |||||
| 35% | 20 | Unfavorable outcome only | 35 (3.5) | ||
| 35% | 20 | other | 369 (36.9) | 596 (59.6) | |
| 35% | 30 | Unfavorable outcome only | 205 (20.5) | ||
| 35% | 30 | TPP only | 2 (0.2) | ||
| 35% | 30 | other | 177 (17.7) | 616 (61.6) | |
| 35% | 40 | Unfavorable outcome only | 517 (51.7) | ||
| 35% | 40 | other | 44 (4.4) | 439 (43.9) | |
| Relative TTP slope: 40% | |||||
| 40% | 20 | Unfavorable outcome only | 35 (3.5) | ||
| 40% | 20 | TPP only | 3 (0.3) | ||
| 40% | 20 | other | 289 (28.9) | 673 (67.3) | |
| 40% | 30 | Unfavorable outcome only | 205 (20.5) | ||
| 40% | 30 | TPP only | 1 (0.1) | ||
| 40% | 30 | other | 98 (9.8) | 696 (69.6) | |
| 40% | 40 | Unfavorable outcome only | 517 (51.7) | ||
| 40% | 40 | other | 12 (1.2) | 471 (47.1) | |
| true.slope | nk | decision | decision2 | n | prop |
|---|---|---|---|---|---|
| -10% | 20 | NO-GO | Unfavorable outcome only | 3 | 0.003 |
| -10% | 20 | NO-GO | TPP only | 436 | 0.436 |
| -10% | 20 | Continue | other | 561 | 0.561 |
| -10% | 30 | NO-GO | other | 24 | 0.024 |
| -10% | 30 | NO-GO | Unfavorable outcome only | 10 | 0.010 |
| -10% | 30 | NO-GO | TPP only | 579 | 0.579 |
| -10% | 30 | Continue | other | 387 | 0.387 |
| -10% | 40 | NO-GO | other | 58 | 0.058 |
| -10% | 40 | NO-GO | Unfavorable outcome only | 17 | 0.017 |
| -10% | 40 | NO-GO | TPP only | 662 | 0.662 |
| -10% | 40 | Continue | other | 263 | 0.263 |
| 10% | 20 | NO-GO | Unfavorable outcome only | 3 | 0.003 |
| 10% | 20 | NO-GO | TPP only | 85 | 0.085 |
| 10% | 20 | Continue | other | 876 | 0.876 |
| 10% | 20 | GO | other | 36 | 0.036 |
| 10% | 30 | NO-GO | other | 4 | 0.004 |
| 10% | 30 | NO-GO | Unfavorable outcome only | 30 | 0.030 |
| 10% | 30 | NO-GO | TPP only | 108 | 0.108 |
| 10% | 30 | Continue | other | 833 | 0.833 |
| 10% | 30 | GO | other | 25 | 0.025 |
| 10% | 40 | NO-GO | other | 13 | 0.013 |
| 10% | 40 | NO-GO | Unfavorable outcome only | 62 | 0.062 |
| 10% | 40 | NO-GO | TPP only | 123 | 0.123 |
| 10% | 40 | Continue | other | 791 | 0.791 |
| 10% | 40 | GO | other | 11 | 0.011 |
| 35% | 20 | NO-GO | Unfavorable outcome only | 3 | 0.003 |
| 35% | 20 | Continue | other | 381 | 0.381 |
| 35% | 20 | GO | other | 616 | 0.616 |
| 35% | 30 | NO-GO | Unfavorable outcome only | 34 | 0.034 |
| 35% | 30 | NO-GO | TPP only | 2 | 0.002 |
| 35% | 30 | Continue | other | 220 | 0.220 |
| 35% | 30 | GO | other | 744 | 0.744 |
| 35% | 40 | NO-GO | Unfavorable outcome only | 75 | 0.075 |
| 35% | 40 | Continue | other | 84 | 0.084 |
| 35% | 40 | GO | other | 841 | 0.841 |
| 40% | 20 | NO-GO | Unfavorable outcome only | 3 | 0.003 |
| 40% | 20 | NO-GO | TPP only | 3 | 0.003 |
| 40% | 20 | Continue | other | 298 | 0.298 |
| 40% | 20 | GO | other | 696 | 0.696 |
| 40% | 30 | NO-GO | Unfavorable outcome only | 34 | 0.034 |
| 40% | 30 | NO-GO | TPP only | 1 | 0.001 |
| 40% | 30 | Continue | other | 113 | 0.113 |
| 40% | 30 | GO | other | 852 | 0.852 |
| 40% | 40 | NO-GO | Unfavorable outcome only | 75 | 0.075 |
| 40% | 40 | Continue | other | 36 | 0.036 |
| 40% | 40 | GO | other | 889 | 0.889 |
Interim analysis decision probabilities for simulated arms with TTP
slope relative to the control as specified in the panels (all
corresponding to the 2 Winners simulation setting) and
unfavorable outcome rates of A) 10% (unfavorable), B) 5% (minimal), and
C) 2.5% (desirable). Arms are flagged for a GO decision if they meet all
the following conditions: fewer than 2 unfavorable outcomes, evidence of
meeting the target product profile, and a posterior probability greater
than 50% of ranking in the top two arms. A pattern is applied to
differentiate the criterion responsible for NO-GO decisions. Arms are
flagged for a NO-GO decision if they experience any of the following
conditions: 2 or more unfavorable outcomes (stripes), do not have
evidence of meeting the target product profile (dots), or meet both
conditions (plain). All arms that do not meet the criteria for a GO or
NO-GO decision, receive a “Continue” designation. Results are based on
1,000 simulated datasets per setting.
Interim analysis decision probabilities for simulated arms with TTP
slope relative to the control as specified in the panels (all
corresponding to the 1 Winner simulation setting) and
unfavorable outcome rates of A) 10% (unfavorable), B) 5% (minimal), and
C) 2.5% (desirable). Arms are flagged for a GO decision if they meet all
the following conditions: fewer than 2 unfavorable outcomes, evidence of
meeting the target product profile, and a posterior probability greater
than 50% of ranking in the top two arms. A pattern is applied to
differentiate the criterion responsible for NO-GO decisions. Arms are
flagged for a NO-GO decision if they experience any of the following
conditions: 2 or more unfavorable outcomes (stripes), do not have
evidence of meeting the target product profile (dots), or meet both
conditions (plain). All arms that do not meet the criteria for a GO or
NO-GO decision, receive a “Continue” designation. Results are based on
1,000 simulated datasets per setting.
Interim analysis decision probabilities for simulated arms with TTP
slope relative to the control as specified in the panels (all
corresponding to the 4 Winners simulation setting) and
unfavorable outcome rates of A) 10% (unfavorable), B) 5% (minimal), and
C) 2.5% (desirable). Arms are flagged for a GO decision if they meet all
the following conditions: fewer than 2 unfavorable outcomes, evidence of
meeting the target product profile, and a posterior probability greater
than 50% of ranking in the top two arms. A pattern is applied to
differentiate the criterion responsible for NO-GO decisions. Arms are
flagged for a NO-GO decision if they experience any of the following
conditions: 2 or more unfavorable outcomes (stripes), do not have
evidence of meeting the target product profile (dots), or meet both
conditions (plain). All arms that do not meet the criteria for a GO or
NO-GO decision, receive a “Continue” designation. Results are based on
1,000 simulated datasets per setting.
Interim analysis decision probabilities for simulated arms with TTP
slope relative to the control as specified in the panels (all
corresponding to the No Winners simulation setting) and
unfavorable outcome rates of A) 10% (unfavorable), B) 5% (minimal), and
C) 2.5% (desirable). Arms are flagged for a GO decision if they meet all
the following conditions: fewer than 2 unfavorable outcomes, evidence of
meeting the target product profile, and a posterior probability greater
than 50% of ranking in the top two arms. A pattern is applied to
differentiate the criterion responsible for NO-GO decisions. Arms are
flagged for a NO-GO decision if they experience any of the following
conditions: 2 or more unfavorable outcomes (stripes), do not have
evidence of meeting the target product profile (dots), or meet both
conditions (plain). All arms that do not meet the criteria for a GO or
NO-GO decision, receive a “Continue” designation. Results are based on
1,000 simulated datasets per setting.
| Regimen | Duration | No. patients | No. relapses | \(\hat{\theta}_{0.5}\) | \(\hat{\theta}_{0.025}\) | \(\hat{\theta}_{0.975}\) | \(P(\theta_k > \theta_{MAV})\) | \(P(\theta_k > \theta_{TV})\) | TPP decision | \(\hat{\psi}_1\) | \(\hat{\psi}_2\) | \(\hat{\psi}_3\) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 26 | 30 | 0 | 0.000 | 0.022 | |||||||
| 2 | 16 | 30 | 1 | 0.111 | -0.129 | 0.422 | 0.808 | 0.263 | Continue | 0.808 | 0.001 | 0.026 |
| 3 | 16 | 30 | 0 | 0.233 | -0.012 | 0.569 | 0.966 | 0.588 | Continue | 0.966 | 0.004 | 0.240 |
| 4 | 16 | 30 | 0 | 0.319 | 0.054 | 0.688 | 0.991 | 0.790 | GO | 0.991 | 0.048 | 0.715 |
| 5 | 16 | 30 | 0 | 0.556 | 0.257 | 0.950 | 1.000 | 0.993 | GO | 1.000 | 0.947 | 0.997 |